Dr. Michael Weinstein: How drug pricing legislation can hurt patients, independent physicians

Counting drug coupons as part of a drug's added sales price could tie the hands of independent clinicians trying to ensure patients get access to affordable and effective care options, said Michael Weinstein, MD.

The Prescription Drug Pricing Act, which the Senate will consider this fall, includes a provision that would require drugmakers to include the value of drug coupons when calculating a drug's average sales price. Dr. Weinstein, president and board chairman of the Digestive Health Physicians Association, elaborated on the proposal and explained how the bill could affect gastroenterologists and patients alike.

Note: Responses were edited for style and clarity.

Question: How would this proposal affect independent physicians?

Dr. Michael Weinstein: Independent physicians treat thousands of patients in our communities. Including the value of coupons and patient assistance programs that pharmaceutical manufacturers provide to patients in the calculation of Medicare's average sales price reimbursement formula could be devastating for patients who need medications that are administered in physician offices. [If approved,] this will affect people living with conditions that require intensive management, such as cancer, rheumatoid arthritis and macular degeneration, among other diseases and chronic conditions.

For gastroenterologists, our patients with Crohn's disease and ulcerative colitis will be hit hardest. Treatment for these diseases is enormously complex and the medications can be expensive, but they are badly needed for people who are suffering from abdominal pain, persistent diarrhea, intestinal bleeding, fever, weight loss and worse.

On top of living with terrible symptoms, many of our patients face increasing cost-sharing burdens imposed by insurance companies and pharmacy benefit managers. As you can imagine, the coupon programs help patients continue with expensive treatments. [Patients recognize significant] savings. According to a recent Health Affairs study, patients can save between $50 and $100 a month.

While the goal seems to be lowering Medicare expenses through a change in [average sales price], the bill could instead cause pharmaceutical companies to eliminate the coupons and patient assistance programs because of the overall effect on their margins. With no change in ASP pricing, Medicare won't save money, but the patients who need financial help the most will experience even higher costs. This could lead our patients to forsake needed treatments and experience more complications, which would thereby increase the cost of care in the long term.

It could also make it harder for medical practices to provide certain medications in the convenience of our offices. Physician practices are already confronting reduced reimbursement as a result of the budget sequestration of 2013. If the Medicare reimbursement rate falls because the value of coupons are included in calculating the ASP, the actual costs for some treatments may not be covered, which could cause physicians to no longer provide those treatments. This would be especially difficult for smaller practices and those in rural or underserved areas.

Q: What sort of alternative options should Congress consider?

MW: We share Congress' goal of ensuring the sustainability of the Medicare program, and recognize the leadership of the Senate Finance Committee in working to lower drug prices. We are generally supportive of the policies in the Prescription Drug Pricing Reduction Act that would reduce beneficiary out‐of‐pocket costs, improve access and price transparency, and increase market competition in the Medicare program. We support the provision that caps out-of-pocket costs for seniors with very high costs.

Patients should have access to safe and effective treatments at the lowest possible cost, and biosimilars can help to bring costs down. We appreciate that there is language in the bill that aims to improve patient access to treatments by supporting biosimilars.

Our major concern about the bill is Section 102, because the changes it would implement to the ASP formula could result in increased out-of-pocket costs and make treatments less accessible. If physician practices can no longer afford to administer these drugs, this policy is likely to force patients to seek care in the more expensive and less convenient hospital setting, where Medicare and patients pay dramatically more for drug administration.

Q: If Congress continues with this proposal, what could independent practices do to prepare?

MW: It's important for GI physicians to be involved in policy advocacy. We have important insights to share about how these policies impact the lives of our patients. We need to participate and work to protect against changes that will negatively affect the patients for whom we care.

On this specific proposal, there are many physician and patient advocacy groups that are working to educate our policymakers about the unintended consequences that the proposal will have on our patients. Were hopeful that we'll be able to work with the Senate Finance Committee to find policy solutions that will reduce costs for patients with Crohn's disease, ulcerative colitis, and other diseases and chronic conditions without weakening access to medications that improve the quality of life for thousands of patients.

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